a study of baricitinib (ly3009104) in participants with moderate to severe atopic dermatitis

Conditions: Atopic Dermatitis

Summary: this open-label study will evaluate the long-term efficacy and safety of baricitinib in adult participants with moderate to severe atopic dermatitis (ad).


Eligibility criteria:
have participated in study jaiw (nct03435081), and meet specific completion requirements for that study, and do not meet any of the following exclusions: * have significant uncontrolled cerebro-cardiovascular (e.g., myocardial infarction \[mi\], unstable angina, unstable arterial hypertension, severe heart failure, or cerebrovascular accident), respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neuropsychiatric disorders, or abnormal laboratory values that developed during a previous baricitinib study that, in the opinion of the investigator, pose an unacceptable risk to the participant if investigational product continues to be administered. * have a known hypersensitivity to baricitinib or any component of this investigational product. * had investigational product permanently discontinued at any time during a previous baricitinib study, except for participants who had investigational product discontinued during originating study because of rescue with an oral systemic ad therapy (e.g., corticosteroid, cyclosporine, methotrexate). * had temporary investigational product interruption continue at the final study visit of a previous baricitinib study and, in the opinion of the investigator, this poses an unacceptable risk for the participant's participation in the study. * pregnant or breastfeeding or • have not participated in a study jaiw (nct03435081) and satisfy the following criteria: inclusion criteria: * have a diagnosis of atopic dermatitis (ad) at least 12 months before screening. * have moderate to severe ad, including all of the following: * easi score ≥16 * iga score of ≥3 * 10%- 50% bsa involvement * have had inadequate response or intolerance to existing topical (applied to the skin) medications within 6 months preceding screening. * are willing to discontinue certain treatments for eczema (such as systemic and topical treatments) * agree to use emollients daily. exclusion criteria: * are currently experiencing or have a history of other concomitant skin conditions (e.g., psoriasis or lupus erythematosus), or a history of erythrodermic, refractory, or unstable skin disease that requires frequent hospitalizations and/or intravenous treatment for skin infections. * a history of eczema herpeticum within 12 months, and/or a history of 2 or more episodes of eczema herpeticum in the past. * participants who are currently experiencing a skin infection that requires treatment, or is currently being treated, with topical or systemic antibiotics. * have any serious illness that is anticipated to require the use of systemic corticosteroids or otherwise interfere with study participation or require active frequent monitoring (e.g., unstable chronic asthma). * have been treated with the following therapies: * monoclonal antibody for less than 5 half-lives before randomization * received prior treatment with any oral janus kinase (jak) inhibitor less than 4 weeks before randomization * received any parenteral corticosteroid administered by intramuscular or intravenous injection within 6 weeks of planned randomization or are anticipated to require parenteral injection of corticosteroids during the study * have had an intra-articular corticosteroid injection within 6 weeks of planned randomization * probenecid at the time of randomization that cannot be discontinued for the duration of the study * have high blood pressure characterized by a repeated systolic blood pressure \>160 millimeters of mercury (mm hg) or diastolic blood pressure \>100 mm hg. * have had major surgery within the past eight weeks or are planning major surgery during the study. * have experienced any of the following within 12 weeks of screening: myocardial infarction (mi), unstable ischemic heart disease, stroke, or new york heart association stage iii/iv heart failure. * have a history of venous thromboembolic event (vte), or are considered at high risk for vte. * have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, lymphoproliferative disease or neuropsychiatric disorders or any other serious and/or unstable illness. * have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection including herpes zoster, tuberculosis. * have specific laboratory abnormalities. * have received certain treatments that are contraindicated. * pregnant or breastfeeding.

Keywords: eczema atopic eczema